Label: EPIONCE DAILY SHIELD TINTED SPF 50- titanium dioxide, zinc oxide lotion

  • NDC Code(s): 42673-005-00, 42673-005-01, 42673-005-02
  • Packager: Episciences, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 3, 2024

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  • Active ingredients

    Titanium Dioxide 4.8%
    Zinc Oxide 9.3%

  • Purpose

    Sunscreen

  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection
      measures (see Directions), decreases the risk of
      skin cancer and early skin aging caused by the sun.
  • Warnings

    For external use only

    Do not use

    • on damaged or broken skin

    Stop use and ask a doctor if

    • rash occurs

    When using this product

    • keep out of eyes.
      Rinse with water to remove.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • at least every two hours
    • children under 6 months: Ask a doctor
    • Sun Protection Measures. Spending time in the
      sun increases your risk of skin cancer and early
      skin aging. To decrease this risk, regularly use a
      sunscreen with a Broad Spectrum SPF value of
      15 or higher and other sun protection measures
      including:
      • limit time in the sun, especially from 10 a.m. - 2 p.m.
      • wear long-sleeved shirts, pants, hats and
        sunglasses
  • Other information

    • protect the product in this container from
      excessive heat and direct sun
  • Inactive ingredients

    Cyclopentasiloxane, Water, Dimethicone

    Crosspolymer, Butylene Glycol, Cetyl

    PEG/PPG-10/1 Dimethicone, Polymethylsilsesquioxane,

    Caprylyl Methicone, PEG-10

    Dimethicone, Argania Spinosa Kernel Oil,

    Glycerin, Disteardimonium Hectorite,

    Isododecane, Tocopheryl Acetate, Alumina,

    Bisabolol, Caprylyl Glycol, Ethylhexylglycerin,

    Helianthus Annuus (Sunflower) Extract,

    Hexylene Glycol, Hydrogen Dimethicone, Iron

    Oxides (C.I. 77491), Iron Oxides (C.I. 77492),

    Iron Oxides (C.I. 77499), Lauryl Polyglyceryl-3

    Polydimethylsiloxyethyl Dimethicone, Oryza

    Sativa (Rice) Bran Extract, PEG/PPG-18/18

    Dimethicone, Phenoxyethanol, Propylene

    Carbonate, Pyrus Malus (Apple) Fruit Extract,

    Rosmarinus Officinalis (Rosemary) Leaf

    Extract, Silica, Sodium Chloride, Tocopherol,

    Triethoxycaprylylsilane.

  • Questions?

    Call toll free 1-866-374-6623

  • PRINCIPAL DISPLAY PANEL

    Daily Shield Tinted Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    EPIONCE DAILY SHIELD  TINTED SPF 50
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42673-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.048 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.093 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ISODODECANE (UNII: A8289P68Y2)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    RICE BRAN (UNII: R60QEP13IC)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    APPLE (UNII: B423VGH5S9)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42673-005-021 in 1 BOX02/27/2017
    1NDC:42673-005-0150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:42673-005-006 g in 1 TUBE; Type 0: Not a Combination Product02/27/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/27/2017
    Labeler - Episciences, Inc. (144733040)
    Registrant - Episciences, Inc. (144733040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Episciences, Inc.144733040manufacture(42673-005)
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